Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
This recall has been terminated (originally issued March 9, 2009).
- Company
- Welch Allyn Protocol, Inc
- Recall Initiated
- December 15, 2008
- Posted
- March 9, 2009
- Terminated
- March 19, 2012
- Recall Number
- Z-1006-2009
- Quantity
- 10, 735
- Firm Location
- Beaverton, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
Distribution
Worldwide Distribution.
Lot / Code Info
Software version 2.02 or lower. The ECG analysis/noise issue involves all units manufactured before January 2006 when a design/component change was made.
Root Cause
Component design/selection
Action Taken
Welch Allyn sent a Customer Recall Notice dated February 26, 2009, to all customers (customer list supplied by distributors). Welch Allyn will upgrade all units with software version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E 820-0178-00.
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